BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACKFLUSH INSTRUMENT

    MDR report key: 10246663 · Received July 8, 2020

    Report

    Report Number
    1222074-2020-00048
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    HMX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNFORTUNATELY, SINCE THE INVOLVED BACK-FLUSH INSTRUMENT WAS NOT RETURNED TO DORC, NO PHYSICAL EXAMINATION OR TESTING COULD BE PERFORMED TO CONFIRM THE REPORTED FAILURE OR TO DETERMINE ITS CAUSE. AS THE LOT NUMBER OF THE INVOLVED PRODUCT WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW PERTINENT TO THE LOT COULD NOT BE PERFORMED. A DATABASE SEARCH FOR POSSIBLE SIMILAR COMPLAINTS ON THE LOT WAS NOT POSSIBLE EITHER. THE COMPLAINT RECORD WAS CLOSED WITH AN INCONCLUSIVE RESULT.

    Additional Manufacturer Narrative · 0

    COMPLAINT ARTICLE WAS REQUESTED BY D.O.R.C. FOR INVESTIGATION. THE COMPLAINT ARTICLE WAS NOT YET RECEIVED BY D.O.R.C. FOR INVESTIGATION. THE CUSTOMER IS EXPECTED TO SEND THE PRODUCT. D.O.R.C. WILL KEEP MONITORING THE SITUATION CLOSELY. NO APPROPRIATE CORRECTIVE/PREVENTATIVE ACTIONS CAN BE TAKEN UNTIL THE INVESTIGATION IS COMPLETED. THE COMPLAINT ARTICLE WAS NOT YET RECEIVED BY D.O.R.C. FOR INVESTIGATION. - ATTACHMENT: [MIR 2020-002654 FOLLOW UP REPORT SIGNED 1222074-2020-00048 FOLLOW UP 1.PDF]

    Description of Event or Problem · 0

    DURING A PROCEDURE A SURGEON INTENDED TO REMOVE PERFLUORCARBON LIQUID (PFCL) FROM THE PATIENT'S EYE. A BACKFLUSH INSTRUMENT WAS USED, BUT IT DID NOT FUNCTION AND DRAINING WAS NOT POSSIBLE. THE SURGERY WAS COMPLETED WITH ANOTHER BACKFLUSH INSTRUMENT. PATIENT HARM DID NOT OCCUR, HOWEVER, THE PROCEDURE WAS PROLONGED.

    Description of Event or Problem · 0

    DURING A PROCEDURE A SURGEON INTENDED TO REMOVE PERFLUORCARBON LIQUID (PFCL) FROM THE PATIENT'S EYE. A BACKFLUSH INSTRUMENT WAS USED, BUT IT DID NOT FUNCTION AND DRAINING WAS NOT POSSIBLE. THE SURGERY WAS COMPLETED WITH ANOTHER BACKFLUSH INSTRUMENT. PATIENT HARM DID NOT OCCUR, HOWEVER, THE PROCEDURE WAS PROLONGED.

    Additional Manufacturer Narrative · 1

    COMPLAINT ARTICLE WAS REQUESTED BY D.O.R.C. FOR INVESTIGATION.

    Description of Event or Problem · 1

    DURING A PROCEDURE A SURGEON INTENDED TO REMOVE PERFLUORCARBON LIQUID (PFCL) FROM THE PATIENT'S EYE. A BACKFLUSH INSTRUMENT WAS USED, BUT IT DID NOT FUNCTION AND DRAINING WAS NOT POSSIBLE. THE SURGERY WAS COMPLETED WITH ANOTHER BACKFLUSH INSTRUMENT. PATIENT HARM DID NOT OCCUR, HOWEVER, THE PROCEDURE WAS PROLONGED FOR MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712738 BACKFLUSH INSTRUMENT VITRECTOMY FLUID/ GAS HANDLING INSTRUMENT HMX D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.

    Patients

    Seq Age Sex Outcome Treatment
    1